CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES

{0}------------------------------------------------ KOH2101 ### SEAL POLYMER INDUSTRIES BERHAD Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300 SMDA 510 (K) SUMMARY 1.0 SEAL POLYMER INDUSTRIES BERHAD 2.0 Submitter Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak, Malaysia (60 5) 322 3200 Tel (60 5) 322 2300 Fax Ms. CHUN CHOOl FONG Name of Contact Person Date of Summary Prepared August 2, 2004 Name of Device 3.0 Powder Free Nitrile Examination Gloves Device Name Exam Glove Common Name Nitrile Patient Examination Glove Classification Name ### Identification of the Legally Marketed Devices 4.0 Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA requirements. #### Description of The Device 5.0 Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the Cluss T Thirne Fullions Channing of 20-00a53 and FDA Water Leak Test. #### 6.0 The Intended Use of Glove A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. > Page 1 of 3 ATTACHMENT O {1}------------------------------------------------ ## SEAL POLYMER INDUSTRIES BERHAD Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300 ### Summary of Performance Data: 7. Performance data of gloves based on ASTM D6319-00a53 and FDA 1000 ml watertight test. | TEST | ASTM D6319-00aE3<br>AQL=2.5% | POWDER FREE NITRILE EXAM<br>GLOVES<br>AQL=2.5% | |----------------------------------------|------------------------------|------------------------------------------------| | 1. Watertight (1000 ml) | G I | Pass G I | | 2. Length (mm)<br>Size | Min 230 | | | XS | Min 230 | 240 mm minimum for<br>all sizes | | S | Min 230 | | | M | Min 230 | | | L | Min 230 | | | XL | Min 230 | | | 3. Palm width (mm)<br>Size | - | | | XS | - | <80 mm | | S | $80 +/- 10$ | $85 +/- 3$ mm | | M | $95 +/- 10$ | $95 +/- 3$ mm | | L | $111 +/- 10$ | $105 +/- 3$ mm | | XL | - | $111 +/- 3$ mm | | XXL | - | $120 +/- 3$ mm | | 4. Thickness (mm)<br>(Single Layer) | | | | Finger | Min 0.05 | 0.08 minimum | | Palm | Min 0.05 | 0.08 minimum | | 5. Physical Properties | | | | Before Aging<br>Tensile Strength (Mpa) | Min 14.0 | 20.7* | | Ultimate Elongation (%) | Min 500 | 609* | | After Aging<br>Tensile Strength (Mpa) | Min 14.0 | 22.9* | | Ultimate Elongation (%) | Min 400 | 597* | | 6. Powder Content | - | Below 2mg / glove | * The average number obtain from Attachment C. {2}------------------------------------------------ ### SEAL POLYMER INDUSTRIES BERHAD Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 -- 322 2300 - The performance data of the glove as showed above meet the ASTM D6319-00a53 8. Standard and FDA's requirement. Standard and I BA 9 row 2mg per glove, which meet the FDA Requirements. - The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea 9. Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests. - Conclusion 10. We concluded that the Powder Free Nitrile Examination Gloves meet the below specifications: - ASTM D6319-00a53 Standard - - FDA pinhole requirements ﺘ - FDA minimum powder residual content ﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ Page 3 of 3 ATTACHMENT O {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the logo for the U.S. Department of Health and Human Services. The logo is a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the perimeter of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 2 7 2004 Ms. Chun Chooi Fong Quality Management System Manager Seal Polymer Industries Berhad Lot 72706, Jalan Lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak, MALAYSIA Re: K042101 K042101 Trade/Device Name: Cashmere Powder Free Nitrile Examination Gloves Green Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 2, 2004 Received: August 4, 2004 Dear Ms. Fong: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(t) profit is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the choiosaro, to tegan. interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate conments, or to tvay 20, 1978, and saiffed in accordance with the provisions of Amendments, of to devices that have boom require approval of a prematical the premarket the Federal Food, Drug, and Cosmetic Pro (110) ------------------------------------------------------------------------------------------------------------------------------approval application (1 Nirf). Fou frols provisions of the Act include controls provisions of the Act. The gentiral of devices, good manufacturing practice, requirements for unitual reagainst misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) into controls. Existing major regulations affecting (PMA), it may be subject to such additional controllations, Title 21, Parts 800 to 898. In the Foderal your device can be found in the Code of Peacharters on the Federal Register. {4}------------------------------------------------ Page 2 - Ms. Fong Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA s Issualics of a substance complies with other requirements mean that FDA has made a determination that your devices with other Federal agencies mean that FDA has made a decemination administered by other Federal agencies. of the Act or any Federal statutes and regulations and not limited to: registration of the Act or any rederal statutes and registerents, including, but not limited to: registration You must comply with all the Act's requirements, including and memorical You must comply with an the Act 3 requirements and 801); good manufacturing practice and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing (21 CFR Par and listing (21 CFR Part 807), labelling (21 CFR Parter (21 CFR Part 820); and if requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) the success of the county of the country of would as a f This letter will allow you to begin matically your as a lovivalence of your device to a premarket notification. The PDA intellige of substance of Submitter on the vice and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your device on our see at (31) 594-4618. Also, please note the regulation please contact the Office of Comphanes are (2011) - 1 CFR Part 807.97). You entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You entitled, "Misoranding by reference to premained on your responsibilities under the tall from the may obtain offer general miormation on Jour Paper Assistance at its toll-free Division of Sinan Manufactacles, 2019, 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # INDICATIONS FOR USE STATEMENT : Seal Polymer Industries Berhad Applicant 510(K) Number : Device Name : Powder Free Nitrile Examination Gloves Green Indication For Use: A patient examination glove is a disposable device intended for medical purposes that is worn er. A patient examination glove is a disposable device michod for meetime paper. on the examiner's hands or finger to prevent contamination between patient and examiner. Prescription Use (Part 21 CFR 801 Subpart D) ( AND/OR Over-The-Counter Use _ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Kein Muling (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: K 042101 Page 1 of ____________________________________________________________________________________________________________________________________________________________________